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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021060

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PRIALT (ZICONOTIDE ACETATE)
100MCG/1ML (100MCG/ML)
Marketing Status: Prescription
Active Ingredient: ZICONOTIDE ACETATE
Proprietary Name: PRIALT
Dosage Form; Route of Administration: INJECTABLE; INTRATHECAL
Strength: 100MCG/1ML (100MCG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021060
Product Number: 002
Approval Date: Dec 28, 2004
Applicant Holder Full Name: TERSERA THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
PRIALT (ZICONOTIDE ACETATE)
500MCG/5ML (100MCG/ML)
Marketing Status: Prescription
Active Ingredient: ZICONOTIDE ACETATE
Proprietary Name: PRIALT
Dosage Form; Route of Administration: INJECTABLE; INTRATHECAL
Strength: 500MCG/5ML (100MCG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021060
Product Number: 004
Approval Date: Dec 28, 2004
Applicant Holder Full Name: TERSERA THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
PRIALT (ZICONOTIDE ACETATE)
500MCG/20ML (25MCG/ML)
Marketing Status: Prescription
Active Ingredient: ZICONOTIDE ACETATE
Proprietary Name: PRIALT
Dosage Form; Route of Administration: INJECTABLE; INTRATHECAL
Strength: 500MCG/20ML (25MCG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021060
Product Number: 001
Approval Date: Dec 28, 2004
Applicant Holder Full Name: TERSERA THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
PRIALT (ZICONOTIDE ACETATE)
200MCG/2ML (100MCG/ML)
Marketing Status: Discontinued
Active Ingredient: ZICONOTIDE ACETATE
Proprietary Name: PRIALT
Dosage Form; Route of Administration: INJECTABLE; INTRATHECAL
Strength: 200MCG/2ML (100MCG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021060
Product Number: 003
Approval Date: Dec 28, 2004
Applicant Holder Full Name: TERSERA THERAPEUTICS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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